Multi-contrast Versus Multi-sequence Carotid MRI

March 18, 2024 updated by: Maastricht University Medical Center

Level of Agreement in the Assessment of Carotid Plaque Composition Between Multi-contrast and Multi-sequence MRI

The objective of this study is to validate 2 multi-contrast sequences, namely the Multi-contrast ATherosclerosis Characterization (MATCH) and Bright-blood and black-blOOd phase SensiTive (BOOST) inversion recovery sequence for the quantification of atherosclerotic plaque components with conventional multi-sequence MRI and histology.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Rationale: Rupture of a vulnerable atherosclerotic plaque is the most important cause of stroke and myocardial infarction. Magnetic Resonance Imaging (MRI) with its high soft tissue contrast is well suited for atherosclerotic plaque imaging to identify high-risk plaques. High soft tissue contrast enables the visualisation of different plaque components based on which the plaque can be classified as stable or vulnerable. To identify the various plaque components, in a conventional MRI examination multiple MRI sequences are acquired, which can take approximately 30-40 minutes. This can be uncomfortable for the patient and it is impractical in daily clinical practice. As an alternative, multi-contrast sequences have recently been developed which acquire multiple contrast weightings simultaneously, significantly reducing the scan time (< 6 minutes). Apart from a reduction in scan time, because these contrast weightings are acquired simultaneously, they are inherently co-registered which is not the case with conventional sequences.

Objective: The objective of this study is to validate 2 multi-contrast sequences, namely the Multi-contrast ATherosclerosis Characterization (MATCH) and Bright-blood and black-blOOd phase SensiTive (BOOST) inversion recovery sequence for the quantification of atherosclerotic plaque components with conventional multi-sequence MRI and histology.

Study design: cross-sectional validation study Study population: 40 patients with a carotid artery plaque ≥2 mm based on ultrasound or Computed Tomography Angiography.

Intervention (if applicable): not applicable Main study parameters/endpoints: the presence and volumetric measures of plaque components (fibrous tissue, lipid-rich necrotic core, intraplaque hemorrhage and calcifications) and volumetric measures of the vessel wall and lumen as assessed with multi-contrast MRI will be compared to those as assessed by conventional multisequence MRI and, if available, histology of the surgically removed specimen in patients that are scheduled for carotid endarterectomy.

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands
        • Recruiting
        • Maastricht University Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

40 patients (18 years or older) with a carotid plaque ≥ 2 mm based on ultrasound or CTA, will be included in this study. These patients will undergo a 3T MRI scan. Inclusion will be done by an investigator. All the research will take place at Maastricht University Medical Centre (MUMC). Vascular surgeons, neurophysiologists and neurologists at MUMC are willing to participate in this study. Some of the included patients will be scheduled for CEA as part of standard clinical care. The MRI scan of these patients will take place at least one day before CEA is performed. At MUMC, approximately 10 patients per month fit the criteria (≥ 2 mm carotid plaque size).

Description

Inclusion Criteria:

In order to be eligible to participate in this study, a subject must meet the following criteria:

  • Patients with a carotid plaque ≥ 2 mm thick based on ultrasound or CTA
  • Age 18 years or older (no maximum age)
  • Informed consent by signing informed consent form regarding this study

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

  • Patients with carotid plaque ≤ 2 mm in size based on ultrasound or CTA
  • Standard contra-indications for MRI (electronic implants like pacemakers or other electronic implants, metallic eye fragments, vascular clips, claustrophobia, etc.)
  • Severe co-morbidity, dementia or pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of Intra Plaque Hemorrhage (IPH)
Time Frame: through study completion, an average of 6 months
The primary objective is to investigate the level of agreement between scoring presence of IPH on MR images acquired with MP-RAGE (conventional sequence) with scoring IPH on the multi-contrast sequences. The level of agreement will be assessed by calculating Cohen's k.
through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scoring the presence of other plaque tissues
Time Frame: through study completion, an average of 6 months
In addition, we will report the sensitivity and specificity of scoring the presence of IPH, a LRNC, calcifications, a thin or rupture fibrous cap, and ulcerations using the multi-contrast images with the scores based on the conventional multi-sequence images as reference standard.
through study completion, an average of 6 months
Calculate correlation between plaque tissues
Time Frame: through study completion, an average of 6 months
To study the correlation between the vessel wall and luminal volume and volumes of calcifications, LRNC and IPH as delineated on the multi-contrast sequences versus the conventional multisequence MRI protocol.
through study completion, an average of 6 months
Correlation between plaque tissues components and histology
Time Frame: through study completion, an average of 6 months
To study the correlation between the presence/volume of calcifications, LRNC, thin or ruptured fibrous cap, ulcerations and IPH as quantified using the multi-contrast MRI sequences and histology.
through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2021

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

September 16, 2020

First Submitted That Met QC Criteria

September 23, 2020

First Posted (Actual)

September 29, 2020

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABR73156

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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